Identity
- Trade Name
- Eargo 5 FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Large Closed Petals FDA UDI
- Model / Reference
- 99-0140-001 FDA UDI
- Description
- Large Closed Petals FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850010429335 FDA UDI
- 510(k) Number
- K221698 FDA UDI
- FDA Product Code
- QUH FDA UDI
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3325 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-conduction hearing aid, in-the-ear
Eargo 5 by Eargo Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, in-the-ear.
- Bernafon — Bernafon, Inc. · Class II
- AUDIBEL — Starkey Laboratories Inc. · Class II
- Unitron — Unitron Hearing · Class I
- AGX — Widex A/S · Class II
- Widex — Widex A/S · Class II
- Ceretone — AUDICON CORPORATION · Class I
- Bernafon — Bernafon, Inc. · Class II
- AUDIGY — Starkey Laboratories Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eargo Inc
Sources (1)
- FDA UDI 8b34c0c3-d629-4c07-90cf-fb6fc0d04f18 35 fields · synced May 30, 2026